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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K150291
Device Name TYRX Neuro Absorbable Antibacterial Envelope
Applicant
MEDTRONIC TYRX, INC.
1 DEER PARK DRIVE SUITE G
MONMOUTH JUNCTION,  NJ  08852
Applicant Contact Regina Novak
Correspondent
MEDTRONIC TYRX, INC.
1 DEER PARK DRIVE SUITE G
MONMOUTH JUNCTION,  NJ  08852
Correspondent Contact Regina Novak
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/06/2015
Decision Date 03/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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